New Hepatitis Vaccine May Soon Be Available

Posted: January 3rd, 2013 | Author: | Filed under: Travel Vaccines Updates | Tags: , , , | Comments Off on New Hepatitis Vaccine May Soon Be Available

California’s Dynavax Technologies scored a win when FDA staff said the company’s Heplisav vaccine works against the contagious liver disease hepatitis B.

The FDA said in a report that Heplisav worked as well after two doses as three doses of GlaxoSmithKline’s Engerix-B vaccine. The vaccine also had a similar safety profile to Engerix-B.

Company stock rose 13% upon the news, closing Tuesday at $4.74. This marks the largest single-day jump since September 2011.

Dynavax does not yet have a product on the market, so Heplisav will be first should the FDA approve the vaccine Feb. 24, when the organization is scheduled to make a decision. The product could rake in an estimated $775 million in worldwide sales come 2020, Katherine Xu, an analyst with William Blair & Co., told Bloomberg.

In a study of about 2,400 patients ages 18 to 55, 95% of those who took two doses of Heplisav were protected from hepatitis B. By comparison, 81% of those who took three doses of Glaxo’s Engerix-B were protected.

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Vaccine Manufacturer Receives Clean Bill of Health from FDA

Posted: October 9th, 2012 | Author: | Filed under: Passport Health Sarasota-Bradenton Announcements | Tags: , , | Comments Off on Vaccine Manufacturer Receives Clean Bill of Health from FDA

After more than two years of manufacturing problems, CSL Biotherapies cleaned up its act, snagging a closeout letter from the FDA.


FDA (Photo credit: Wikipedia)

The FDA slapped the company with a warning letter in June 2011, questioning CSL’s manufacturing quality.  Its processes may have contributed to issues with a flu vaccine and led to the hospitalization of several children in 2010.  Australian regulators put a halt to licensing Fluvax for children under age 5 at the time.

CSL’s missteps included failing to adequately investigate dark particles found in some vials and completing only a limited analysis of the manufacturing process to determine why the adverse events shot up in 2010 compared with previous seasons.  “There was no analysis of all critical parameters and critical processing steps to determine differences in the 2010 lots associated with adverse events reports compared to lots from previous seasons,” the warning letter says.

As for the dark particles, the FDA investigation focused on multidose vials only.  Analysis of the particles showed that they were “discolored influenza virus with the possible presence of mercury compounds,” according to the warning letter.  The company refuted this, saying the dark particles were not foreign to the product.  The FDA disagreed.

The closeout letter comes a few weeks after CSL announced that the company’s CEO, Brian McNamee, will step down next July.  He’ll be replaced by the current president of CSL Behring, Paul Perreault.